Statue of justice

AstraZeneca Wins a Federal Court Ruling – Upholds Key Patent for Diabetes Drug, Farxiga

Authored by The Rx Advocates, / Medically Reviewed by Dr. Conor Sheehy, PharmD, BCPS
Last Updated: February 6, 2022

Over the last several years, the incidence of Type 2 Diabetes has been on the rise. Consequently, there are more medications to combat the symptoms and complications of diabetes than there have ever been before.

More medications can also mean more competition. Producers of name brands and generic replications are battling for top rank. One of those drugs, Farxiga, recently won a patent infringement suit.

A company that produces generic medications tried unsuccessfully to circumvent the patent to manufacture a similar product before the expiration of the existing patent held by Farxiga.

Typically, generic medications contain the same “active ingredients” but can add any number of inactive ingredients.

During the patent period, manufacturers of brand-name medications can still research and improve their products during the patent period.

 

The AstraZeneca Court Ruling

In May 2021, Zydus Cadila entered into an infringement lawsuit against AstraZeneca claiming the patent for its diabetic drug, Farxiga, was not valid.

Zydus Cadila, a generic-drug producer, in an attempt to begin manufacturing a generic form of the drug, argued that AstraZeneca should not have received the patent in the first place because it merely “covers an obvious variation of an old idea.”

US District Court Judge Richard Andrews rejected Zydus’s arguments, citing they did not present convincing evidence or factual findings for their challenge of the patent. AstraZeneca’s existing patent is set to expire in 2025.

Zydus is involved in two other patent infringement cases with AstraZeneca over the cancer drug Tagrisso.

 

What is Diabetes?

Diabetes is a chronic health condition that affects how your body turns food into energy.

When food is broken down in the digestive system, blood sugar is elevated, signaling the pancreas to release insulin, which allows the body’s cells to use it as energy.

Someone is considered diabetic if their pancreas doesn’t make enough insulin or the body does not efficiently use the insulin produced.

There is no cure for diabetes, but the disease can be managed with healthy eating, exercise, and medication.

Three types of Diabetes

  • Type 1 Diabetes – Type 1 was previously called “juvenile diabetes” because the onset was often diagnosed in children, teens, or young adults and is the least common type. It is considered an autoimmune disorder, since the body reacts by limiting or stopping the production of insulin.
  • Type 2 Diabetes – Type 2 is termed “insulin resistant” and usually occurs in those over 45 or who are overweight. Cells do not respond properly to the insulin released by the pancreas, which may cause the pancreas to try to produce more until it can no longer keep up.
  • Gestational Diabetes – Some women develop diabetes during a pregnancy, which usually disappears after giving birth.

 

Type 2 Diabetes is on the Rise

Type 2 Diabetes was previously considered a disease that affected the middle-aged or elderly population, but it has become more prevalent in young adults and even children.

In 1998, the American Diabetic Association (ADA) projected that 6.2% of the world’s population (328 million people) would be afflicted with Type 2 Diabetes by 2025.

The ADA now projects that the number is expected to increase to 578 million (10.2%) in 2030 and 700 million (10.9%) in 2045.

The World Health Organization (WHO) reports that the number of people diagnosed with Type 2 Diabetes globally rose from 108 million in 1980 to 422 million in 2014 (from 4.7% to 8.5%).

While genetics may factor into the onset of Type 2 Diabetes, more than heredity plays a role. Lifestyle choices seem to be a greater factor in today’s world.

Modern conveniences, technology, fast food options, and a population on-the-go create a lack of healthy choices that can help prevent diabetes.

How to Delay the Onset of Diabetes

  • Physical activity – try to get at least 30 minutes of physical activity at least five days a week. Avoid sedentary behaviors.
  • Healthy eating – eat healthy foods most of the time; avoid sugar and refined carbs; lower carb consumption; watch portion size.
  • Drink water – water keeps the body hydrated and keeps kidneys healthy.
  • Maintain normal body weight – an overweight person may delay the onset by losing 5-7% of their body weight.
  • Avoid tobacco.
  • Limit alcohol consumption.

 

Treatment Options

Type 1 diabetes is most often treated with insulin, though a Type 2 patient that does not respond to other treatments may also undergo insulin therapy. When diagnosed with Type 2 Diabetes, the first course of treatment is often beginning one or more oral medications with the suggestion of adopting a healthier lifestyle.

Diabetes left untreated can lead to chronic and sometimes fatal complications, such as heart disease, stroke, kidney failure, circulatory issues, nerve damage, and eye disease.

Common diabetic medications may stimulate the production of insulin, reduce blood sugar production or absorption, or introduce hormones similar to those which help the body release insulin. Farxiga is considered a Sodium-glucose transporter (SGLT) 2 inhibitor, a class of drugs that also offers protection against kidney failure and heart disease. These are two important factors when choosing the most beneficial diabetic medication.

Common Diabetes Medications

  • Biguanides – decrease sugar production in the liver or how much sugar the intestines absorb. Currently, the only biguanide on the market is Metformin sold under brand names including Janumet and Invokamet
  • Dipeptidyl peptidase-4 (DPP-4) inhibitors – help the body continue to make insulin. They work by reducing blood sugar without causing hypoglycemia. Brand names – Tradjenta, Onglyza, Januvia, Nesina
  • Glucagon-like peptide-1 (GLP-1) receptor agonists – similar to the natural incretin hormones,, which increases B-cell growth and how much insulin the body uses. Brand names: Bydureon, Ozempic, Trulicity, Victoza
  • Meglitinides – helps the body release insulin. Brand names: Prandin, Starlix
  • Sodium-glucose transporter (SGLT) 2 inhibitors – prevent the kidneys from holding glucose. Brand names: Farxiga, Invokana, Jardiance
  • Sulfonylureas – work to stimulate the pancreas to make more insulin. Brand names: Amaryl, Glucotrol, Glynase
  • Thiazolidinediones – decrease the glucose in the liver. Brand names: Actos

 

Get Help Paying for Farxiga through The Rx Advocates

At The Rx Advocates, we offer financial assistance to people who are struggling to afford their monthly medication costs. If you take monthly medications for Type 2 Diabetes, you already know how expensive they can be.

The Rx Advocates can help. Contact us to learn how you could receive help getting the cost of your diabetes medication covered.

 

Source:

American Diabetes Association. Diabetic Care
https://care.diabetesjournals.org/content/27/7/1798

Diabetes.com. Drug Class
https://www.drugs.com/drug-class/meglitinides.html

Farxiga.com
https://www.farxiga.com/

Harvard Health Publishing. Diabetes
https://www.health.harvard.edu/

Health Line. Type 2 Diabetic Medications
https://www.healthline.com/health/diabetes/medications-list#type-2-diabetes

The Mayo Clinic. Types of Diabetes
https://www.mayoclinichealthsystem.org/hometown-health/speaking-of-health/types-of-diabetes

The National Library of Medicine. Medications for Type 2 Diabetes
https://www.ncbi.nlm.nih.gov/books/NBK279506/

World Health Organization. Type 2 Diabetes Facts
https://www.who.int/news-room/fact-sheets/detail/diabetes

Bloomberg/Quint. AstraZeneca Wins Ruling Upholding Key Patent for Diabetes Drug.
https://www.bloombergquint.com/business/astrazeneca-wins-ruling-upholding-key-patent-for-farxiga

CDC. What is Diabetes?. https://www.cdc.gov/diabetes/basics/diabetes.

NIH. Sodium-glucose co-transporter type-2 inhibitors: pharmacology and peri-operative considerations. https://pubmed.ncbi.nlm.nih.gov/29529345/.

Diabetes.co.uk. Biguanides. https://www.diabetes.co.uk/diabetes-medication/biguanides.html.

US National Library of Medicine/NIH. Glucagon-Like Peptide 1 Receptor Agonists for Type 2 Diabetes. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5556578/.

Diabetes Self Management. Incretin Hormone: Definition and Overview.
https://www.diabetesselfmanagement.com/diabetes-resources/definitions/incretin-hormone/.

Drugs.com. Meglitinides. https://www.drugs.com/drug-class/meglitinides.html.

NCBI. Sulfonylureas. https://www.ncbi.nlm.nih.gov/books/NBK513225/.

NCBI. Thiazolidinediones. https://www.ncbi.nlm.nih.gov/books/NBK551656/.

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